Duke University and Duke University Health System - Durham, NC

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Position Summary:
Perform routine on-site and in-house site assessments for clinical
research activities with minimal
direction for several dozen sites. Use critical thinking skills to
assess sites' eligibility
including feasibility for a particular program as well as monitoring
sites' compliance with study,
sponsor, organizational, and government guidelines including the
Megatrials Quality by design
Guiding Principles. Collect, document, update, and report study
information according to established
procedures and timelines using standard templates. Follow up,resolve,
and report on issues
identified during study monitoring and assessment activities with
guidance. Independently document
routine study start-up activities and site communication. Prepare
project-specific plans for
startup activities, including developing, distributing, and collecting
essential study document
packages and negotiating site contracts and study budgets. Manage data
cleaning for their

Primary Responsibilities and Tasks:
1. Oversee
and review routine site activities for clinical trials research, with
guidance, through
monitoring activities, including on-site visits and/or in-house
assessments, including telephone
contact and other technologies, according to the trial-specific
monitoring plan to assess protocol,
regulatory, and SOP compliance with guidance from experienced CRA or
clinical trial lead. Perform
study start-up activities for multiple sites according to the study
specific plan. Assess
sites' regulatory compliance, including but not limited to informed
consent review and review of
investigative regulatory files.

a. Prepare project-specific plans for start up activities, including
developing, distributing, and
collecting essential study document packages and negotiating site
contracts and study budgets. May
travel to perform on-site monitoring visits, including site selection,
initiation, periodic, and
close out visits. Schedule site visits according to DCRI travel policy
and trial-specific guidelines
while using cost and time saving efficiencies.
b. Assess protocol and regulatory compliance, including but not limited
to, source document
verification, informed consent process and human subject protection,
data integrity, drug
accountability and compliance, and review of investigator and
regulatory files. Identify and report
protocol, SOP, and regulatory/GCP deviations.
c. Assess adequacy of site personnel and facilities for study
d. Provide study training and guidance to designated site personnel for
conducting the
study in
accordance with the protocol, SOPs, trial specific procedures and
applicable regulations. Identify
Subject safety and data integrity issues and retrain site personnel
e. Identify action items and discuss with appropriate site personnel.
Communicate routine
unusual findings to trial supervisor. Document ongoing follow-up and
resolution of issues.
f. Assist sites with preparation for planned audits.

2. Document routine site management and clinical monitoring activities,
site communication,
trial related activities with guidance. Utilize monitoring tools and
trial documents, adapting and
editing standard templates as directed

a. Apply knowledge of protocol and study documents and processes,
during monitoring
including on-site visits and in-house assessments, in response to site
activities and inquiries.
b. Regularly review study and site status information and enter updates
into required
systems to
maintain accurate, current reports.
c. Prepare and submit accurate and timely confirmation letters,
monitoring reports, follow-up
letters and expense reports, using standard templates and forms, in
accordance with SOPs and
d. Maintain essential trial and site communication records, electronic
and hard copy,
non-essential communication as directed.
e. Develop and implement action plans for resolution of identified site
and study issues.
Follow up
on outstanding issues including ongoing documentation.
3. Manage and review site data including case report form (CRF)
completion and
submission, data
query resolution, and overall data integrity according to established
processes including the
Megatrials Quality by Design Guiding Principles.
a. Review specified patient data and source documents. Appropriately
report safety
protocol deviations and unexpected data trends.
b. Review data status reports and follow-up with sites regarding
missing and/or late data.
c. Provide training for site personnel on appropriate source
documentation, CRF completion,
procedures and timelines, and query resolution. Review data queries,
assist sites with query
resolution and follow up on outstanding queries.
4. Build and maintain effective working relationships with site
personnel, and internal and
study contacts.
a. Maintain appropriate professional relationships utilizing an
assertive, business-like manner
which fosters study compliance.
b. Provide timely notification to appropriate study contacts of site
status and trial related
c. Provide clear direction to site and trial personnel as directed
while following project
guidelines and professionally representing the DCRI and the DCRI's
d. Contribute topositive team dynamics through effective listening and
verbal communication
including active participation in team meetings, interactionwith team
members, sharing information,
and proactive problem identification and resolution.

5. Provide routine updates and reports to trial supervisor(s) and other
assigned contacts to
timely communication regarding status of sites, study issues and
resolutions, and trial activities.

a. Communicate with teammates to consolidate accurate and complete
assessments of
activities. Routinely report updates to trial supervisor without
b. Routinely communicate with internal partners as needed for trial
c. Utilize trial supervisor as a resource for assessing findings and
planning resolution of

Other Duties:
# Maintain job knowledge and skills through independent self-study.
# Actively
support the DCRI and the Commercial Mega Trials functional
Review education and training experience with line manager and complete
identified training needs
within designated time period.
Complete administrative activities accurately and in a timely manner,
e.g., time tracking,
attendance reports, training file.
Attend functional group meetings.
Participate in 360 feedback activities for self and others for annual
performance evaluations.
Participate in special assignments as requested by supervisors.
# Perform other related
duties incidental to the work described
herein. Minimum Qualifications
Education Work requires graduation from an accredited degree program providing clinical training as a Registered Nurse (RN), Physician's Assistant (PA) or Pharmacist plus one year of healthcare experience; or one of the following equivalents: Completion of an allied health degree (e.g., Respiratory Therapy, Radiologic Technology, Licensed Practical Nurse) or Associates degree in Clinical Trials Research related curriculum plus a minimum of three years healthcare experience; or Completion of a master's degree in Public Health, Health Administration or a related area with no additional experience; or Completion of a bachelor's degree plus a minimum of one year directly related experience in clinical trials research; or Completion of a bachelor's degree plus a minimum of two years closely related research experience. **State of North Carolina license may be required.**
Experience None required beyond that described above. OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE

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Duke University Health System is a world-class health care network dedicated to providing outstanding patient care, educating tomorrow's...